Nucleoside Reverse Transcriptase Inhibitors

Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor

HIV Infections

Hepatitis B, Chronic

<section class="Section" data-sectioncode="34089-3"><a name="S11"></a><a name="section-10"></a><h1>11 DESCRIPTION</h1>BIKTARVY (bictegravir, emtricitabine, and tenofovir alafenamide) is a fixed dose combination tablet containing bictegravir (BIC), emtricitabine (FTC), and tenofovir alafenamide (TAF) for oral administration.<ul class="Disc"><li>BIC is an integrase strand transfer inhibitor (INSTI).</li><li>FTC, a synthetic nucleoside analog of cytidine, is an HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI).</li><li>TAF, an HIV NRTI, is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate.</li></ul>BIKTARVY tablets are available in two dose strengths:<ul class="Disc"><li>50 mg/200 mg/25 mg tablet containing 50 mg of BIC (equivalent to 52.5 mg of bictegravir sodium), 200 mg of FTC, and 25 mg of TAF (equivalent to 28 mg of tenofovir alafenamide fumarate).</li><li>30 mg/120 mg/15 mg tablet containing 30 mg of BIC (equivalent to 31.5 mg of bictegravir sodium), 120 mg of FTC, and 15 mg of TAF (equivalent to 16.8 mg of tenofovir alafenamide fumarate).</li></ul>Both dose strengths of BIKTARVY tablets include the following inactive ingredients: croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. The tablets for both dose strengths are film-coated with a coating material containing iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.<div class="Section" data-sectioncode="42229-5"><a name="section-10.1"></a>Bictegravir: The chemical name of bictegravir sodium is 2,5-Methanopyrido[1',2':4,5]pyrazino[2,1-b][1,3]oxazepine-10-carboxamide, 2,3,4,5,7,9,13,13a-octahydro-8-hydroxy-7,9-dioxo-N-[(2,4,6-trifluorophenyl)methyl]-, sodium salt (1:1), (2R,5S,13aR)-.Bictegravir sodium has a molecular formula of C21H17F3N3NaO5 and a molecular weight of 471.4 and has the following structural formula:<img alt="Chemical Structure" src="biktarvy-01.jpg"/>Bictegravir sodium is an off-white to yellow solid with a solubility of 0.1 mg per mL in water at 20 °C.</div><div class="Section" data-sectioncode="42229-5"><a name="section-10.2"></a>Emtricitabine: The chemical name of FTC is 4-amino-5-fluoro-1-(2R-hydroxymethyl-1,3-oxathiolan-5S-yl)-(1H)-pyrimidin-2-one. FTC is the (-)enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5 position.FTC has a molecular formula of C8H10FN3O3S and a molecular weight of 247.2 and has the following structural formula:<img alt="Chemical Structure" src="biktarvy-02.jpg"/>FTC is a white to off-white powder with a solubility of approximately 112 mg per mL in water at 25 °C.</div><div class="Section" data-sectioncode="42229-5"><a name="section-10.3"></a>Tenofovir alafenamide: The chemical name of tenofovir alafenamide fumarate drug substance is L-alanine, N-[(S)-[[(1R)-2-(6-amino-9H-purin-9-yl)-1-methylethoxy]methyl]phenoxyphosphinyl]-, 1-methylethyl ester, (2E)-2-butenedioate (2:1).Tenofovir alafenamide fumarate has an empirical formula of C21H29O5N6P∙½(C4H4O4) and a formula weight of 534.5 and has the following structural formula:<img alt="Chemical Structure" src="biktarvy-03.jpg"/>Tenofovir alafenamide fumarate is a white to off-white or tan powder with a solubility of 4.7 mg per mL in water at 20 °C.</div></section>

Biktarvy

tenofovir alafenamide

bictegravir / emtricitabine / tenofovir alafenamide

bictegravir

bictegravir 50 MG / emtricitabine 200 MG / tenofovir alafenamide 25 MG Oral Tablet

bictegravir 50 MG / emtricitabine 200 MG / tenofovir alafenamide 25 MG Oral Tablet [Biktarvy]

bictegravir 30 MG / emtricitabine 120 MG / tenofovir alafenamide 15 MG Oral Tablet

bictegravir 30 MG / emtricitabine 120 MG / tenofovir alafenamide 15 MG Oral Tablet [Biktarvy]

emtricitabine

Psoriasis (PsO)

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Ankylosing Spondylitis (AS)

Nonradiographic Axial Spondyloarthritis

Taltz

Juvenile Idiopathic Arthritis

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Crohn's Disease (CD)

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Skyrizi

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Migraine

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Emgality

Qulipta

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Ubrelvy

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Verzenio

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Kisqali

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Cibinqo

Eucrisa

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Prurigo Nodularis

Dupixent

Opzelura

Adbry

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Lorbrena

Alecensa

Alunbrig

NSCLC cMET Mutation

Xalkori

Rheumatoid Arthritis (RA)

Xeljanz

Uveitis

Graft Versus Host Disease (GVHD)

Orencia

COVID-19 Treatment

Alopecia Areata

Olumiant

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Zeposia

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Entyvio

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